Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa

Novartis

Status and phase: Active, not recruiting; Phase 3

Conditions: Hidradenitis Suppurativa

Treatments: Drug: secukinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04179175

2019-003230-17 (EudraCT Number)

CAIN457M2301E1

Details and patient eligibility

About

The purpose of this extension study is to evaluate maintenance of Hidradenitis Suppurativa Clinical Response (HiSCR response) in either continuous or interrupted therapy (using a randomized withdrawal period) of two dose regimens and to assess long-term efficacy, safety and tolerability of Secukinumab in subjects with moderate to severe hidradenitis suppurativa completing either of the 2 Phase III studies. This is an expanded access trial for the core trials CAIN457M2301 (NCT03713619) and CAIN457M2302 (NCT03713619).

Full description

This is a multicenter extension study to both core Phase III studies CAIN457M2301 and CAIN457M2302 (Core studies). This study contains a randomized withdrawal design, double blinded and placebo controlled up to Week 104 or loss of response. The subjects with HiSCR response after 52 weeks of treatment in the "Core studies" will be randomized at 2:1 ratio to either continue on one of the two Secukinumab dosing regimens assigned in "Core studies" for another 52 weeks or will be placed on placebo. The primary endpoint is loss of response (LOR) assessed during the 52-week treatment duration (up to Week 104). Subjects who attained LOR will be transferred to open-label treatment to continue until the end of the study. Subjects on placebo who did not reach LOR up to Week 104 will be offered to continue in the open-label treatment or discontinue the study. Thus for subjects who were HiSCR responders at Week 52 of "Core studies", the open label treatment duration will vary and start either from the time of LOR or from Week 104 dose and last until Week 260 followed by 8 weeks of a post treatment follow-up period to week 268.

Subjects who were HiSCR non-responders at the end of "Core studies" will be offered to continue in open-label treatment until Week 260.

Subjects who prematurely discontinue the study, or who complete the study will enter a post-treatment follow up period (8 weeks) The primary objective is to evaluate maintenance of HiSCR response at Week 104 in either continuous or interrupted therapy compared to placebo. Secondary objectives are to assess the long-term safety and tolerability evaluated by adverse events, abnormal laboratory values and vital signs.

Enrollment: 704 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• written informed consent must be obtained before any assessment is performed
• subject must have completed the study treatment period (52 weeks) in the core studies (AIN457M2301 or AIN457M2302) and had received secukinumab treatment during Treatment Period 2

Exclusion criteria

• protocol deviation in the core study which will prevent the meaningful analysis of the extension study
• ongoing or planned use of prohibited HS or non-HS treatment
• participation in the extension could expose the subject to an undue safety risk
• current sever progressive or uncontrolled disease which renders the subject unsuitable for the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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704 participants in 5 patient groups, including a placebo group

secukinumab 1 HiSCR Responder

Active Comparator group

Description:

HiSCR responder at Week 52 in core trial, secukinumab 300mg every 2 weeks

Treatment:

Drug: secukinumab

Drug: secukinumab

secukinumab 2 HiSCR Responder

Active Comparator group

Description:

HiSCR responder at Week 52 in core trial, secukinumab 300mg every 4 weeks

Treatment:

Drug: secukinumab

Drug: secukinumab

placebo 1 HiSCR Responder

Placebo Comparator group

Description:

HiSCR responder at Week 52 in core trial, placebo to secukinumab 300mg every 2 weeks

Treatment:

Drug: secukinumab

Drug: secukinumab

placebo 2 HiSCR Responder

Placebo Comparator group

Description:

HiSCR responder at Week 52 in core trial, placebo to secukinumab 300 mg every 4 weeks

Treatment:

Drug: secukinumab

Drug: secukinumab

HiSCR non-responders

Other group

Description:

non-responder at Week 52 in core trial treatment; secukinumab 300mg every 2 weeks

Treatment:

Drug: secukinumab

Drug: secukinumab